en
Schlagwörter
Pharmakovigilanz
Stufenplanbeauftragter
Pharmacovigilance
QPPV
Arzneimittelsicherheit
Drug safety
Medicinal products
drugs
medical devices
PSMF
RMP
CCDS
SPC
SmPC
Schulung
Trainings
Audit
Auditor
Inspektionen
Inspection
Qualitätssicherung
Qualitätsmanagement
Prozessoptimierung
Interim Management
Pharma
Graduated plan officer
Graduated plan commissioner
Literaturrecherche
literature search
Regulatory Compliance
Skills
15 years experience in pharmacovigilance with hands-on approach and strong background in clinical medicine (internal medicine, gastroenterology, emergency medicine).
More than 10 years in pharmaceutical industry in pharmacovigilance- and medical leadership positions on a local and global level, including worldwide safety responsibility for innovative pharmaceutical products, generics and development compounds and medical devices.
All pharmacovigilance duties and responsibilities can be covered, including EU QPPV, local (German) Qualified Person responsible for Pharmacovigilance and medically trained person (please refer to list of projects).
An experienced librarian cam also be included in pharmacovigilance projects.
More than 10 years in pharmaceutical industry in pharmacovigilance- and medical leadership positions on a local and global level, including worldwide safety responsibility for innovative pharmaceutical products, generics and development compounds and medical devices.
All pharmacovigilance duties and responsibilities can be covered, including EU QPPV, local (German) Qualified Person responsible for Pharmacovigilance and medically trained person (please refer to list of projects).
An experienced librarian cam also be included in pharmacovigilance projects.
Projekthistorie
Pharmacovigilance is a matter of trust: excellent references will be named on request.
Pharmacovigilance experience / Project list
• German Graduated Plan Officer (Stufenplanbeauftragter) acc. to §63a AMG
• EU QPPV as per GVP Module I, I.C.1.3
• Medically trained person acc. to Commission Implementing Regulation (EU) No 520/2012 Art. 10 (1)
• Setting-up and maintaining PV systems, creation and implementation of PSMF
• Implementation of national (Germany)/international (EU) legal PV requirements
• Developing and establishing local and global PV standards, SOPs, PV templates, training, KPIs
• Medical/scientific responses upon requests from physicians, pharmacists, patients
• Medical/scientific responses to regulatory authorities
• Preparation and performance of pharmacovigilance training for various audiences
• Development and implementation of Risk minimization measures
• Data entry in pharmacovigilance databases, MedDRA coding, medical assessments of ICSRs from clinical trials and post-marketing experience
• Cumulative safety signal detection & evaluation, benefit/risk evaluations, signal assessment reports
• Creation/maintenance of safety profile documents, e.g. CCDS, SmPC, IB
• Lead investigator and safety responsible for (non-) interventional clinical studies (first in men, phase I-IV)
• Creation and review of (periodic) safety reports PSURs/PBRERs, RMPs, DSUR/PBRER
• Management of medical alert situations incl. product recalls, DHCP letters
• Preparation/establishment of PV Agreements / SDEAs
• PV due diligence, benefit/risk analyses for in-licensing of compounds/products
• Health Authority inspections / internal PV auditing incl. CAPA development
Pharmacovigilance experience / Project list
• German Graduated Plan Officer (Stufenplanbeauftragter) acc. to §63a AMG
• EU QPPV as per GVP Module I, I.C.1.3
• Medically trained person acc. to Commission Implementing Regulation (EU) No 520/2012 Art. 10 (1)
• Setting-up and maintaining PV systems, creation and implementation of PSMF
• Implementation of national (Germany)/international (EU) legal PV requirements
• Developing and establishing local and global PV standards, SOPs, PV templates, training, KPIs
• Medical/scientific responses upon requests from physicians, pharmacists, patients
• Medical/scientific responses to regulatory authorities
• Preparation and performance of pharmacovigilance training for various audiences
• Development and implementation of Risk minimization measures
• Data entry in pharmacovigilance databases, MedDRA coding, medical assessments of ICSRs from clinical trials and post-marketing experience
• Cumulative safety signal detection & evaluation, benefit/risk evaluations, signal assessment reports
• Creation/maintenance of safety profile documents, e.g. CCDS, SmPC, IB
• Lead investigator and safety responsible for (non-) interventional clinical studies (first in men, phase I-IV)
• Creation and review of (periodic) safety reports PSURs/PBRERs, RMPs, DSUR/PBRER
• Management of medical alert situations incl. product recalls, DHCP letters
• Preparation/establishment of PV Agreements / SDEAs
• PV due diligence, benefit/risk analyses for in-licensing of compounds/products
• Health Authority inspections / internal PV auditing incl. CAPA development
Reisebereitschaft
Weltweit verfügbar
